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临床试验/NCT04600635
NCT04600635Unknown不适用

Effect of Confinement on Circadian Rhythms of Patients Integrated Into a Care Pathway for Bariatric Surgery

University Hospital, Grenoble0 个研究点目标入组 500 人开始时间: 2020年11月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
主要终点
Change in sleep and meal schedules

研究概览

简要总结

Confinement disrupts social habits, the absence of professional activity or teleworking creates the possibility for individuals to work and/or sleep at times that are most convenient for them. Investigators hypothesize that subjects with a history of obesity will tend, during confinement, to return to their spontaneous chronotype. The evolution of chronotypes between the pre-confinement period and during confinement will allow to measure the percentage of subjects who are not usually living according to their spontaneous chronotype, due to social constraints. Finally, we wish to retrospectively question the subjects on the impact of confinement on their eating habits, physical activity, mood, employment, and so on.

详细描述

Sleep patterns, evaluated in hunter-gatherer populations, show that without artificial interference, sleep is of course concomitant with the decrease in luminosity, but is also regulated by the outside temperature. Light pollution from night lighting and artificially regulated temperature contribute to distancing us from these physiological signals. In addition, the leisure activities linked to the screens encourage a voluntary restriction of sleep manifested by a later bedtime, whereas social constraints always impose the time of getting up. Sleep debt accumulates during the week and compensates for non-working days inducing a social jet lag of small amplitude, but repeated each week. Subjects who spontaneously or habitually develop a late chronotype (i.e. a propensity to be a "late sleeper, late riser") are the most exposed to this social jetlag between days worked when the sleep debt accumulates and days off when the sleep debt compensates.

It has been widely demonstrated that a short sleep duration promotes weight gain. Subjects with a late chronotype associate a short sleep duration on days when they work and a significant social jetlag on days when they do not work. This late chronotype is associated with unfavourable eating behaviour and more emotional eating and constitutes a risk of developing metabolic diseases.

Confinement disrupts social habits: lack of work activity or teleworking creates the possibility for individuals to work and/or sleep at times that are most convenient for them. Investigators hypothesize that subjects with a history of obesity will have tended, during confinement, to return to their spontaneous chronotype. The evolution of chronotypes between the pre-confinement period and during confinement will allow to measure the percentage of subjects who are not usually living according to their spontaneous chronotype, due to social constraints. Finally, we wish to retrospectively question the subjects on the impact of confinement on their eating habits, physical activity, mood and employment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult (>18 years-old, no upper limit)
  • •Included in the care pathways that prepare and then follow bariatric surgery
  • •Who have an e-mail address and internet access

排除标准

  • •Subjects refusing to participate
  • •Subjects who stayed in a country that did not organize containment during the COVID-19 pandemic.

结局指标

主要结局

Change in sleep and meal schedules

时间窗: before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)

次要结局

  • Change in mood and anxiety assessed by the Hospital Anxiety and Depression Scale (HADS)(before (mid-March 2020) at the end (May 11, 2020))
  • Change in working status(before (mid-March 2020) at the end (May 11, 2020))
  • Change in food security status assessed by the Household Food Security Scale Measure (HFSSM)(before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).)
  • Change in self-reported body weight(before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020))
  • Change in obesity-related quality of life evaluated by EQVOD questionnaire(before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).)
  • Change in physical activity assessed by the short form of International Physical Activity Questionnaire (sf-IPAQ)(before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).)
  • Search for a correlation between evolution of the chronotype and evolution of the weight, IPAQS score, HADS score, etc.(before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

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